Definition

Whether an adverse event's nature and severity are consistent with the applicable reference safety information (product label, IB, or RSI).

Example

If 'nausea' is listed in the product label but 'hepatic necrosis' is not, a case of nausea is expected while hepatic necrosis is unexpected, potentially triggering expedited reporting.

Regulatory source

ICH E2A, ICH E2D

Common mistakes

Confusing expectedness with seriousness or frequency. A rare but listed event is still expected; a common but unlisted event is unexpected.

Inspector question

What reference document do you use for expectedness assessment? How do you handle events partially matching label language?

Related terms